Latest news with #regulatoryCompliance
Entrepreneur
2 days ago
- Business
- Entrepreneur
Zango AI Raises USD 4.8 Mn Round Led by Nexus Venture Partners
The funding will be used to scale teams in Bengaluru and London, and to further develop Zango's AI-native Governance, Risk, and Compliance (GRC) product suite. You're reading Entrepreneur India, an international franchise of Entrepreneur Media. Regulatory compliance startup Zango AI has raised USD 4.8 million in a seed funding round led by Nexus Venture Partners, with participation from early backers South Park Commons, Richard Davies (CEO, Allica Bank), Alan Morgan (Senior Partner at McKinsey), Mark Ransford (Notion Capital), No Label Ventures, and Start Ventures. The funding will be used to scale teams in Bengaluru and London, and to further develop Zango's AI-native Governance, Risk, and Compliance (GRC) product suite. The company also plans to expand into adjacent verticals such as insurance and asset management, building on its success in banking. Founded in 2024 by second-time entrepreneurs Ritesh Singhania and Shashank Agarwal, Zango AI offers a regulatory compliance platform that combines AI-powered agents with human expertise to automate critical compliance functions like horizon scanning, gap analysis, and controls testing. The company operates out of San Francisco, London, and Bengaluru and is already used by major financial institutions including Novobanco, Monzo, and Juni. Zango's cloud-native platform leverages regulatory-domain-specific large language models to build intelligent agents that continuously track regulatory changes, flag compliance gaps in real time, and ensure institutions remain audit-ready — eliminating the need for manual reviews and spreadsheets. "We don't sell a platform — we sell a solution," said Ritesh Singhania, Co-founder of Zango. "Our AI agents are paired with humans-in-the-loop to ensure 100% accuracy. Peace of mind doesn't come from a tool; it comes from a result. That's why we win against consultants — because they don't just sell software, and neither do we." Both founders bring deep domain experience: Singhania previously founded ClearGlass, a pension regulation platform, while Agarwal co-founded Third Watch, an AI fraud detection startup acquired by Razorpay. Anand Datta, Partner at Nexus Venture Partners, said, "The global regulatory landscape is ripe for disruption. Ritesh and Shashank bring a first-principles approach, uniquely marrying AI with compliance expertise. Zango is already augmenting compliance teams and boosting efficiency at global institutions."
Yahoo
25-06-2025
- Business
- Yahoo
Worldline response to EIC
Worldline Group press release following the publication of articles by the European journalism network EIC - 25 June 2025 Worldline operates in a demanding and constantly evolving regulatory environment, especially the one related to HBR (High Brand Risk) sectors, such as online casinos, online stockbrocking or adult dating services. Since 2023, the Group has strengthened its merchant risk framework to ensure full compliance with laws and regulations, conducted a thorough review of its HBR portfolio— which currently accounts for approximately 1.5% of its acquired volumes — and has terminated commercial relationships deemed non-compliant with its strengthened merchant risk framework. As indicated in previous financial communications, these decisions affected merchants representing €130 million run rate revenue in 2024. As an indication, according to the latest international schemes reports, Worldline's fraud ratio is below the industry average. All HBR clients still active within this portfolio are now subject to enhanced oversight, based on specific procedures. Additional requirements in terms of controls, verifications and evidence documentation have been introduced to ensure ongoing alignment with regulatory obligations and our enhanced internal standards. Worldline has progressively ramped up its first and second-line resources to implement the enhanced requirements as part of the ongoing Group-wide Financial Crime Compliance (FCC) strategy to pursue reinforcement of supervision and controls with regular engagement with the relevant regulatory authorities. Wherever the Group identifies indications of non-compliant situations, additional checks are immediately undertaken, potentially leading to termination of the client relationship. Worldline's Executive Management and Board of Directors are fully committed to strict compliance with regulation and risk prevention standards and to strictly enforce related rules and procedures with zero-tolerance. Attachment Worldline response to EIC_June25
Yahoo
24-06-2025
- Business
- Yahoo
FDA Regulatory Compliance for Drug and Biotech Products - 2 Day Virtual Training Course, July 16-17, 2025: Enhance Compliance Skills with Expert-Led Training and Resources
Enhance your regulatory compliance skills with a comprehensive course on FDA regulations for biologics and drug development. Learn practical applications for ensuring compliance with the FD&C Act and GMP regulations in drug manufacturing and testing. Attendees receive presentation slides, a participation certificate, a Q&A session, and free compliance handouts. Dublin, June 24, 2025 (GLOBE NEWSWIRE) -- The "FDA Regulatory Compliance for Drug and Biotech Products (ONLINE EVENT: July 16-17, 2025)" training has been added to offering. Enhance your knowledge of Regulatory Compliance with this specialized live seminar focused on the essential practices mandated by the Federal Food, Drug, and Cosmetic Act. Dive into the practical applications necessary for ensuring adherence to FDA regulations in biologics and drug development, a critical component for both sponsors and regulatory agencies. This seminar offers an insightful exploration of the graded approach in compliance, vital for pharmaceutical and biotechnology companies striving to meet Good Manufacturing Practice (GMP) regulations effectively. This includes the meticulous management needed in manufacturing, testing, and controlling clinical supplies, as well as overseeing commercial product outputs. This live training Seminar includes the following for each registered attendee: A copy of the presentation slides by download A certificate of participation for attendee training records Q/A Session Free Handouts on FDA Regulatory Compliance This course will benefit professionals involved in working with pharmaceutical and Biotech products and management involved in drug development and FDA Regulatory Compliance: QA/QC analytical chemists QA/QC directors, managers Investigators in QA/QC Manufacturing/Production Research and Development Project management Manufacturing personnel CROs analysts Technical liaison Regulatory affairs personnel CMC specialists Senior quality managers Quality professionals Regulatory professionals Compliance professionals Quality auditors Document control specialists New hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. Course Agenda: Day 1 FDA and its Statutory and Regulatory Requirements FDA's Structure and Purpose The Federal Food, Drug and Cosmetic Act The Code of Federal Regulations Guidane, Policy Documents and Compliance Manuals The Evolution of FDA Law Brief Overview: The Products FDA Regulates and Their Pathways to Market Drugs Medical Devices Food & Dietary Supplements Cosmetics Tobacco Veterinary Products Universal Requirements Establishment Registration, Product Listing, User Fees, etc. FDA Drug Development and Approval Process Considerations Statutory and Regulatory Provisions Citizen Petitions Approvals and Clearances The Drug IND, NDA, ANDA and Orphan Designation Biologic's BLA Medical Device 510(k) and PMA Combination Products Veterinary INAD, NADA, ANADA, MUMS FDA Drug Approval Process Case Study # 1: Suitability Petitions Case Study #2: Paragraph IV Certification Post Approval Submissions QbD product development and design Key elements of IND, NDA/ANDA applications and FDA expectations Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway) Post approval changes to process, methods etc. Regulatory Filings Risk analysis Statutory and Regulatory Compliance The Concepts of "Adulteration" and "Misbranding" Identifying Non-Compliance Product Label and Labeling The Internet Approval and Clearance Facility Inspections Adverse Events Recalls Trade Complaints and Anonymous Tips FDA's Compliance Options, Historical Case Examples & FDA's Website Form 483s Untitled Letters Warning Letters Import Alerts Seizures Recalls Consent Decrees Temporary and Permanent Injunctions Civil and Criminal Prosecution The Park Doctrine Other Compliance Bodies DOJ, FTC, EPA, the States, NAD Management's Role and Responsibilities in Compliance Communication, Implementation and Decision Making Quality Policy and Resourcing Personnel Training Escalation of issues to upper management Corrective and Preventive Actions (CAPA) Gap Analysis Facility Audits and Inspections Internal Company Audits Training the Employees Use of Third-Party Auditors Auditor qualifications understanding Learn Key critical audit areas Internal auditing procedures and schedule Supplier and Customer Audits FDA Inspections Foreign Inspections The FDA Form 483 Strategies for Successfully Responding to a Form 483 including Inspection Observations and Violations The Written Response Communication with FDA Disagreements with Form 483 Observations When the Form 483 Becomes a Warning Letter Course Agenda Day 2 Manufacturing and Quality Controls for Drug Products Management's Role and Involvement Complying with Good Manufacturing Practices "cGMPs" Laboratory Quality Controls Standard Operating Procedures What Makes a Good SOP How to Write an Adequate SOP Strategies for Drafting Recalls and Market Withdrawals FDA Jurisdiction and Authority Stock Rotations Corrections Market Withdrawals Recalls Recall Classifications How to Conduct a Product Recall Customer Communication FDA Communication Documentation Strategies for Mitigating the Chances of a Recall Pharmacovigilance Definitions of Significant and Serious Adverse Events Recording, Investigating and Reporting Complaints FDA Communication Strategies for Dealing with Complaints Customs, Detentions and Import Alerts The Process Holds and Detentions Seizure and Destruction Remediating The Import Alert Rx Drug Promotion and Advertising Risk Considerations "Fair Balance" Elements & Considerations Brief Summary Boxed Warning Important Safety Information False and Misleading Claims Fair Balance Superiority Claims Testimonials Market Research Quality of Life Data Other Considerations Enforcement Action Examples Emerging Compliance Trends Counterfeit drug issues and growing concerns Drug shortage crisis Biosimilar approval pathways Others Other Compliance Issues Questions & Answers and Closing Thoughts For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Finextra
18-06-2025
- Business
- Finextra
Changing Regulatory Perceptions: Towards Strategy & Collaboration
Joining the FinextraTV studio at EBAday 2025, Liliana Fratini Passi, Managing Director, CBI shared her insights surrounding a key conversation at the event: regulatory compliance. Fratini Passi shared a belief that the perception of regulation is moving toward one of a strategic driver as opposed to an obstacle or inconvenience. Touching on Instant Payments in particular, Fratini Passi said that the approaches have drastically changed in recent times but that, in her opinion, the most successful ones tend to be those a collaborative nature.
Tahawul Tech
23-05-2025
- Business
- Tahawul Tech
cybersecurity growth Archives
Uraz Farukh, Vice President – Saudi & Bahrain at Seclore, discusses with the company's decade-long journey in Saudi Arabia at GISEC Global 2025. Farukh shared insights about the evolving cybersecurity landscape, and the role of regulatory compliance in driving market maturity. He also focused on the talent development, regional expansion, and why Saudi and the UAE are leading the Middle East's cyber future.
